Telephone-Based Support for Caregivers of Patients With Dementia

Dementia Clinical Trial

Official title:

A Telephone Intervention for Dementia Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052104
• Other study ID #: R21MH062561
• Secondary ID: R21MH062561DSIR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 22, 2003
• Last updated: August 7, 2013
• Start date: December 2001
• Est. completion date: November 2005

Study information

• Verified date: March 2008
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop an effective, low-cost, telephone-based intervention to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients with dementia. This study will also determine whether the intervention can alter the course of dementia.

Description:

Caregivers are randomized to receive either telephone-based intervention or standard medical care. Both groups receive a resource packet containing information about caring for someone with dementia and a list of local resources. Caregivers in the intervention group also receive a series of telephone calls over 12 months, during which education, emotional support, and training in problem-solving skills are provided by trained therapists. Caregivers in the standard care group receive no additional psychosocial intervention. Participants are assessed pre-treatment, mid-treatment (6 months), post-treatment, and at a 3-month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Patient Inclusion Criteria:

• DSM-IV diagnosis of dementia (vascular, mixed, or associated with Alzheimer's disease)

• Lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers

• 50 years old or older

• Resides in Southeastern New England

Caregiver Inclusion Criteria:

• Living with a person with dementia

• Provides care for at least 6 months for at least 4 hours a day

• English as primary language

• Telephone access

• Resides in Southeastern New England

Patient Exclusion Criteria:

• Major acute medical condition affecting independent functioning

Caregiver Exclusion Criteria:

• Acute medical illness

• Cognitive impairment as defined by an MMSE score < 25

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Cognitive-Behavioral Family Systems Intervention

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,